FEATURED EDITORIAL
It may have taken a modern-day war, one much involved with the free navigation of commercial shipping. After more than 100 years navigating a policy of protectionism – and frankly, fear of competition – are we on the cusp of again waiving the Jones Act? This would allow foreign-owned tankers to move oil between U.S. ports. But let’s not temporarily waive it. Let’s sink the Jones Act forever.
- SUS Interchangeability Assessment And Qualification Best Practices
- Delivery Strategy For Next-Gen Cardiac Gene Therapies
- Accelerating Technology Diffusion In Cell And Gene Therapy
- A Woman Relegated To The Manufacturing Night Shift
- 5 QMS Blind Spots You Should Know About
- Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
- A Biotech Business Model That's Investor-Friendly
GUEST COLUMNISTS
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Delivery Strategy For Next-Gen Cardiac Gene Therapies
As the field matures, the most transformative gene therapies in heart health are treating delivery not as an afterthought but as a fundamental principle.
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Accelerating Technology Diffusion In Cell And Gene Therapy
Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.
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5 QMS Blind Spots You Should Know About
Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.
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Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
The outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.
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Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE
By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.
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Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.
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The Real Reason We Haven't Fully Automated Cell Therapy Yet
Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.
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The Firefighting Era Of Clinical Supply Chain Is Over. Here's What Replaces It
Clinical trial supply chains are evolving: digital twins, on-demand kits, and sustainable logistics replace reactive firefighting with precision, speed, and resilience.
PHARMA OUTSOURCING WHITE PAPERS
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Antibody-Based Drug Discovery At The Speed Of Light
Review this end-to-end workflow, including First-to-Human antibody development strategies, the use of the PentaMice® platform for targeted immunization, and the precision of single B cell screening.
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Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
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Bioconjugates – An Increasing Diversity, A Blossoming Of Therapeutic Applications
Harness the power of bioconjugation to revolutionize targeted therapies, enhance drug efficacy, and reduce side effects, paving the way for more precise and effective treatments across a range of diseases.
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Reducing ADC Timelines With Integrated Development And Manufacturing
ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.
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Leak Rate Testing for Freeze Dryers: A Scientific Approach
Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.
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Project Management: Sphere Of Influence
The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Real-Time Monitoring Of Solvent Clearance By TFF In The ADC Process
- Lyophilization To Enable Drug Products Containing Labile Molecules
- Solid-State Characterization Of A Small Molecule API
- Partnering With Health Systems: Essential Tips For CGT Commercialization
- Mitigating Powder Flow And Static Issues Using SYLOID® Mesoporous Silica
NEWSLETTER ARCHIVE
REPORTING
PRODUCTS & SERVICES
ON-DEMAND WEBINARS
- From Model To Molecule: Combining AI And Experimental Strategies To Transform Drug Development
- Strategies For Robust Process Characterization And Validation To Accelerate Biologics Manufacturing
- Translating Stem Cell Programs To GMP
- Innovating Upstream Manufacturing For The Next Wave Of Gene Therapies
- Delivering Value In Clinical Trial Services By Managing Complexity, Timelines